The Effect of Pressure-controlled Ventilation-volume Guaranteed Mode

Anesthesia Clinical Trial

Official title:

Comparison of Pressure-controlled Ventilation-volume Guaranteed Mode With Volume Controlled Ventilation in Prone Position During Lumbar Spine Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571854
• Other study ID #: 2017-I036
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: July 28, 2018

Study information

• Verified date: June 2018
• Source: Hallym University Medical Center
• Contact: Jung Min Lee, MD
• Phone: +82-31-380-3943
• Email: vanilla228[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The anesthetized patient is turned to the prone position during lumbar spine surgery. The dynamic compliance of lung usually decreases and peak airway pressure increases during the surgery.

A new ventilation mode, pressure-controlled ventilation with volume guaranteed mode (PCV-VG) has been recently introduced. The ventilator compares the tidal volume of the previous breath and automatically regulates the pressure up or down to achieve the set tidal volume.

This prospective, randomized study is designed to compare the effect of PCV-VG and volume-controlled ventilation (VCV) on peak airway pressure, lung compliance and hemodynamic variables.

Description:

1. Total 34 patients with American Society of Anesthesiologists physical status I-III who underwent lumbar spine surgery in prone position were enrolled.

2. All patients fasted for 8 hours before the surgery and were premedicated with intramuscular glycopyrrolate 0.2 mg. Anesthesia was induced with remifentanil (0.1-0.2 ug/kg/min), propofol (1.5-2 mg/kg) and rocuronium (0.6 mg.kg) and maintained with sevoflurane (2.0-2.5 vol%) in inspired oxygen fraction with 0.5, remifentanil (0.05-0.3 ug/kg/min) and vecuronium (0.03-0.05 mg/kg/hr).

3. A 20 G catheter was inserted into the radial artery to monitor continuous arterial pressure and hemodynamic variables (cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) monitoring.

4. All patients were ventilated with a Datex-Ohmeda Ventilator (S/5 AVANCE). Patients were randomized to receive either PCV-VG (n=17) or VCV (n=17) mode. The tidal volume in both group were set to deliver 8 mL/kg of ideal body weight. The respiratory rate (RR) was adjust to maintain end tidal CO2 (ETCO2) 33-38 mmHg.

5. Hemodynamic variables (mean blood pressure, heart rate, cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) , respiratory variables (saturation, RR, ETCO2, peak airway pressure, mean airway pressure and lung dynamic compliance) and arterial gas analyses were recorded at 4 stages: (1) 15 minutes after induction in supine position, (2) 30 minutes after turning the patient to the prone position, (3) 60 minutes after turning the patient to the prone position, (4) 15 minutes after turning the patient to supine position at the end of surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 28, 2018
• Est. primary completion date: July 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who were scheduled for lumbar spine surgery with the prone position

• American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

• Age under 20 years old or over 70 years old

• Body mass index > 30 kg/m2

• Systolic blood pressure < 100 mmHg

• Heart rate < 60 bpm

• Uncompensated cardiac disease

• FEV1 < 60%

• Hypoxemia (PaO2 < 60 mmHg or oxygen saturation < 90%)

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Group PCV-VG
Pressure controlled ventilation-volume guaranteed
• Group VCV
Volume controlled ventilation

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Dongan-gu

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Dion JM, McKee C, Tobias JD, Sohner P, Herz D, Teich S, Rice J, Barry ND, Michalsky M. Ventilation during laparoscopic-assisted bariatric surgery: volume-controlled, pressure-controlled or volume-guaranteed pressure-regulated modes. Int J Clin Exp Med. 2014 Aug 15;7(8):2242-7. eCollection 2014. — View Citation

Jo YY, Kim JY, Kwak YL, Kim YB, Kwak HJ. The effect of pressure-controlled ventilation on pulmonary mechanics in the prone position during posterior lumbar spine surgery: a comparison with volume-controlled ventilation. J Neurosurg Anesthesiol. 2012 Jan;24(1):14-8. doi: 10.1097/ANA.0b013e31822c6523. — View Citation

Keszler M. Volume-targeted ventilation. Early Hum Dev. 2006 Dec;82(12):811-8. Epub 2006 Oct 27. Review. — View Citation

Pu J, Liu Z, Yang L, Wang Y, Jiang J. Applications of pressure control ventilation volume guaranteed during one-lung ventilation in thoracic surgery. Int J Clin Exp Med. 2014 Apr 15;7(4):1094-8. eCollection 2014. — View Citation

Song SY, Jung JY, Cho MS, Kim JH, Ryu TH, Kim BI. Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation. Korean J Anesthesiol. 2014 Oct;67(4):258-63. doi: 10.4097/kjae.2014.67.4.258. Epub 2014 Oct 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak airway pressure	The highest level of pressure applied to the lungs during inhalation	About 2-3 hours through the surgery